VP, Quality Assurance

Key responsibilities:

• Lead to identify, develop and implement the business strategy for the Quality department.
• Develop and agree upon operating procedures / business processes
• Head over (executive and senior) management team meetings
• Review audit reports (e.g., process, project, vendor), as applicable
• Maintain and develop organizational culture, values and reputation
• Report to applicable internal stakeholders on business strategy, planning, results and performance for the Quality department.
• Support regulatory authority inspections as needed
• Represent Quality organization in key meetings (e.g., Monthly Business Review, Board).
• Monitor and assure client satisfaction on existing projects for the Quality department
• Identify key accounts and maintain strong long-lasting relationships to win new and repeat business

Requirements

• We're looking for someone with:
• Life science, healthcare and/or business degree
• Minimum 15 years of relevant work experience
• Minimum 12 years of experience in drug development and/or clinical research
• Thorough knowledge of ICH-GCP (R3), auditing, GDPR, FDA and international quality management system regulations and expectations (e.g., 21 CFR Part 11) and applicable (local) regulatory requirements
• Process oriented
• Strong analytical skills
• Decision-making capabilities
• Critical thinking skills
• Management skills including, but not limited to, oversight of teams
• Representative, outgoing and client focused
• Ability to work in a fast-paced challenging environment of a growing company
• Strong leadership skills
• Excellent presentation and networking capabilities
• Excellent organizational, negotiating and financial skills
• Strong Business Acumen

Benefits

• Competitive salaries and a comprehensive benefits package
• Departmental Study/Training for furthering professional development
• Mentoring opportunities
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program
• Eligibility for our internal employee recognition programs for going above and beyond on projects
• Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees

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